Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
Information source: New York University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Depression
Intervention: Bupropion (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: New York University Official(s) and/or principal investigator(s): Michael Marmor, PhD, Principal Investigator, Affiliation: Department of Environmental Medicine, New York University
Summary
The primary purpose of this study was to test the whether high-risk, HIV-seronegative
persons with mild-to-moderate depression would be more likely to adopt protective behavior
change when provided with pharmacotherapy for their depression than when treated with
placebo. High-risk behaviors include using illegal drugs and participating in unprotected
sexual intercourse. The specific pharmacotherapy used in this study was the
anti-depressant, bupropion. The subject population consisted of HIV negative men who have
sex with men (MSM) with mild-to-moderate depression.
Clinical Details
Official title: Drug Abuse, Depression and Responses to HIV Counseling
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.
Secondary outcome: Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing) Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.
Detailed description:
Depression in men is often masked by high-risk behaviors such as alcohol and drug abuse.
Common symptoms among depressed men include feelings of hopelessness and helplessness,
irritability, and anger. MSM are among those at highest for HIV acquisition due to
high-risk behaviors, including unprotected sexual intercourse and drug abuse. Bupropion is
an antidepressant medication commonly used to treat depression. The purpose of this study
thus was whether bupropion could help MSM with mild-to-moderate depression reduce their
high-risk behaviors.
Participants in this trial were randomly assigned to receive either bupropion or placebo for
6 months. Study visits lasting approximately 2 hours each occurred at Day 0, and at Months
4, 6, and 9; included in these visits were physical examination, testing for HIV and
sexually transmitted disease (STD), depression screening, and an interview-administered
questionnaire inquiring into sexual activity and drug use. Shorter study visits, lasting 15
- 30 minutes each occurred at Day 15, and Months 1, 2, 4, 5, and 7, and included depression
screening and physical exam.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Available for at least 9 months, or the duration of the study
- Willing to complete HIV testing and counseling
- History of HIV testing and counseling
- At high risk of HIV infection, indicated by more than one male sexual partner in the
3 months prior to study entry
- Meets criteria for either (a) major depression or dysthymia within a mild-to-moderate
level according to standard criteria DSM-IV, or (b) minor depression as defined by
one or more of the following symptoms at any time and for any duration during the
past 12 months: significant weight loss or gain, or significant decrease or increase
in appetite; poor sleep pattern; noticeable irritability or slowness; fatigue or lack
of energy; inappropriate feelings of worthlessness or guilt; inability to
concentrate; indecisiveness; and recurrent thoughts of death or suicide.
Exclusion Criteria:
- HIV infected
- Sexual intercourse in the 3 months prior to study entry with only one partner, and in
a monogamous relationship
- Currently enrolled in another study involving repeated HIV testing and counseling
- Receiving treatment for depression with antidepressant medication for any length of
time within the year prior to study entry
- Currently in psychotherapy, psychoanalysis, or any other form of talk therapy for any
reason
- Severe depression or at suicidal risk
- No evidence or prior history of depression
- Homicidal or other similar problem that, in the opinion of the investigator, may
endanger study staff and participants
- Currently taking monoamine oxidase inhibitors (MAOIs). Participants may be allowed
to enroll 14 days after discontinuing use of a MAOI.
- History of seizures
- History or current symptoms of bipolar disorder
Locations and Contacts
Bellevue Hospital Center, New York, New York 10016-3240, United States
New York University School of Medicine, New York, New York 10016-3240, United States
Additional Information
Related publications: Thomas SM, Tse DB, Ketner DS, Rochford G, Meyer DA, Zade DD, Halkitis PN, NĂ¡das A, Borkowsky W, Marmor M. CCR5 expression and duration of high risk sexual activity among HIV-seronegative men who have sex with men. AIDS. 2006 Sep 11;20(14):1879-83. Marmor M, Hertzmark K, Thomas SM, Halkitis PN, Vogler M. Resistance to HIV infection. J Urban Health. 2006 Jan;83(1):5-17. Review. Halkitis PN, Zade DD, Shrem M, Marmor M. Beliefs about HIV non-infection and risky sexual behavior among MSM. AIDS Educ Prev. 2004 Oct;16(5):448-58. Marmor M, Penn A, Widmer K, Levin RI, Maslansky R. Coronary artery disease and opioid use. Am J Cardiol. 2004 May 15;93(10):1295-7.
Starting date: September 2002
Last updated: May 17, 2012
|